Long Time, No Post

Sorry for the recent delay in posting.  I hope everyone had a Happy Thanksgiving!  My whole family got together which was great!  I have kept very busy lately, so I haven't had many chances to get on here to post.  Also, our computer got a virus, so we had to fix that before I could post.

And now, some news from the NMSS website:

The company Opexa Therapeutics (The Woodlands, TX) announced that the experimental therapy Tovaxin® has been designated by the U.S. Food and Drug Administration as a “Fast Track Product” for the treatment of secondary-progressive MS. Tovaxin is a personalized vaccine that aims to induce immunity against T cells that attack the brain and spinal cord in MS. It uses a person’s own immune cells, which are removed, manipulated, and then reintroduced by under the skin injections. The Fast Track designation may expedite its future review by the FDA after the company submits results of future phase III trials. The company is planning to begin a Phase IIb clinical trial of Tovaxin in secondary-progressive MS “subject to securing the necessary resources,” according to a November 8, 2011 press release.
Results so far: A one-year, multi-center trial of Tovaxin was conducted in 140 people with relapsing-remitting MS and 10 people who had experienced a neurological episode that put them at possible risk for being diagnosed with MS. The TERMS study found Tovaxin to be safe, but did not achieve statistical significance in the primary endpoint evaluating the cumulative number of active MRI lesions in those on active therapy versus those on placebo (Multiple Sclerosis, published online November 6). Analyzing a subset of participants after the study, investigators found that Tovaxin stabilized or reduced disability as measured by the EDSS scale, and the average number of relapses in a year.
Tovaxin is a trademark of Opexa Pharmaceutics.

This is VERY exciting because its focus is secondary-progressive MS rather than relapsing-remitting, which is what most therapies treat. Another article off of the NMSS website:

Genzyme has announced that the experimental intravenous therapy alemtuzumab (with a proposed brand name Lemtrada™) met two primary endpoints by significantly reducing relapse rates and the worsening of disability in a two-year study comparing alemtuzumab to standard subcutaneous dosing of Rebif® (interferon beta-1a, EMD Serono Inc. and Pfizer). The study, called CARE-MS II, involved 840 people with relapsing-remitting MS. The results were announced in a November 14, 2011 press release, which also indicated that the company plans to apply in early 2012 to the U.S. Food and Drug Administration for marketing approval. Data analysis is ongoing and the company expects to provide a full report at an upcoming medical meeting. Alemtuzumab has been designated by the FDA as a “Fast Track Product,” which should expedite its future review.
Background: MS involves immune system attacks against brain and spinal cord tissues. Alemtuzumab is a humanized monoclonal antibody directed at CD52 (a protein on the surface of immune cells) that is currently approved for the treatment of B-cell chronic lymphocytic leukemia. Its ability to target immune cells led investigators to test its potential as a treatment for relapsing-remitting MS. In an earlier phase II study comparing two dose levels of alemtuzumab with Rebif in 334 subjects with relapsing-remitting MS, those taking alemtuzumab had a 74% reduction in the risk of MS relapse compared with those on Rebif, and a 71% reduction in the risk for sustained worsening of disability (New England Journal of Medicine 2008 359;17:30-45).
Dosing was temporarily suspended in the Phase II study due to the occurrence of immune thrombocytopenic purpura (ITP), a rare condition in which low blood platelet counts can lead to abnormal bleeding. After the first cases of ITP occurred, one of which was fatal, Genzyme implemented a patient safety monitoring program which includes patient and physician education and regular contacts with patients.
Investigators recently reported on another phase III trial of alemtuzumab. The two-year CARE-MS-I phase III trial compared alemtuzumab against Rebif in 581 people with early relapsing-remitting MS. The study met one of two primary endpoints by reducing relapse rates by 55% over Rebif, but did not meet its second primary endpoint of slowing disease progression compared to Rebif. (Abstract #151, ECTRIMS 2011)
This Study: In the CARE-MS II study, 840 people with relapsing-remitting MS, who had experienced relapse while on a prior therapy, were randomly assigned to receive alemtuzumab or Rebif. Alemtuzumab was given by intravenous infusion for 5 days initially and for 3 days one year later. Those on Rebif received the standard dose of 3-times weekly subcutaneous injections. According to the company press release, after two years the relapse rate of those on alemtuzumab was reduced by 49% compared to those on Rebif, and the risk of sustained worsening of disability (as measured by the EDSS scale) was reduced by 42% compared to Rebif. (These were the primary endpoints of the study.)
According to the press release, approximately 16% of those treated with alemtuzumab developed autoimmune thyroid-related problems and approximately 1% developed ITP. All cases were detected early through a monitoring program and managed with conventional therapies. Other common adverse events associated with alemtuzumab included reactions associated with infusions (such as headache, rash, fever, flushing, hives and chills). The most common infections in those treated with alemtuzumab (all mild to moderate) were upper respiratory and urinary tract infections, sinusitis and herpes simplex infections.
Comment: The completion of this second Phase III trial of alemtuzumab is a milestone that paves the way for the company to apply to the FDA for marketing approval. Full details and evaluation of this study should help define the safety and promise of alemtuzumab as a potential new therapy for relapsing MS.

Love the ongoing research; I remain optimistic that a cure will come in my lifetime!  So many advances have been made in just the past decade alone!

Happy Veteran's Day + BG-12 Update

First, I want to thank the veterans for their service and dedication to our country, our safety, and our freedom!  

With that said, I attended an MS dinner/presentation last night about Stress and MS.  I cannot say that I really learned anything new, but it was a good reminder to keep stressors in check and to be sure to have a good coping system.  Life is stressful, MS adds extra stress, and we need to be able to have coping mechanisms in place to minimize the affects of stress.

Now for the BG-12 update (from the NMSS website):

Biogen Idec announced that the experimental oral therapy BG-12 significantly reduced the average number of annual MS relapses in a two-year, Phase III clinical trial of more than 1400 people with relapsing-remitting MS. Although its exact mode of action is not known, BG-12 is thought to inhibit immune cells and molecules involved in MS attacks on the brain and spinal cord. The results of the CONFIRM study were announced in an October 26 press release. Data analysis is ongoing and the company expects to provide a full report at an upcoming medical meeting. Positive results from another Phase 3 trial of BG-12 were also announced this year, paving the way for a potential application for marketing approval.

Background: Multiple sclerosis involves immune system attacks against brain and spinal cord tissues. Although its exact mechanism of action is not known, BG-12, an oral drug, is thought to inhibit immune cells and molecules and may be protective against damage to the brain and spinal cord. In an earlier phase II study, compared to inactive placebo, the highest tested BG-12 dose led to a 69% reduction in gadolinium-enhanced (a contrast agent) disease activity on MRI scans from weeks 12 to 24. Earlier in 2011, Biogen Idec announced positive results in another phase III study, the DEFINE trial. Further details on these results were presented at the joint meeting of the European and Americas Committee for Treatment and Research in MS (ECTRIMS/ACTRIMS) last week.

This Study: The primary goal of the CONFIRM study was to determine whether BG-12 could reduce the average annual MS relapse rate at two years. Secondary objectives included assessing BG-12’s effects on the proportion of people who had relapses, disability progression, and disease activity detected by MRI. Safety and tolerability were also assessed.
Participants were randomly assigned to one of two treatment groups receiving different oral doses (240 mg twice each day and 240 mg three times each day), a group receiving glatiramer acetate (Copaxone®, Teva Pharmaceutical Industries, an approved, injected therapy for MS) or a group receiving placebo. Both BG-12 groups and Copaxone were compared to the placebo groups, but not to each other.

According to the press release, in both groups taking BG-12, the primary endpoint was met; the average number of MS relapses in a year was reduced by 44% versus placebo in the lower-dose group, 51% in the higher-dose group, and 29% in the Copaxone group. Disease activity on MRI and the proportion of patients experiencing relapses also were reduced significantly more in the BG-12 groups versus placebo. Disability progression was not reduced significantly more in the BG-12 groups than in the placebo group. According to the press release, the most common adverse events in the BG-12 groups were flushing and gastrointestinal events.

Comment: Full details and evaluation of this study should help to define further the safety and promise of BG-12 as a potential therapy for relapsing MS. According to the company press release, these positive results set the stage for upcoming filings for marketing approval from drug regulatory agencies.

It is so exciting to learn that another oral therapy is doing well!  Hopefully soon, injections will be a thing of the past for all of us.  In the meantime, stick with what works.

New News from MSF

In this post: How cool would it be if MS could be diagnosed just by exhaling, BG-12 is showing progress, and odd hours may be a increase the risk of MS in teens, and should we be discussing walking problems with our doctors more?

The following is from my most recent email from the Multiple Sclerosis Foundation.

Diagnosing MS from Exhaled Breath

Scientists are reporting the development and successful tests in humans of a sensor array that can diagnose MS from exhaled breath, an advance that they describe as a landmark in the long search for a fast, inexpensive, and noninvasive test for MS. Their report appears in the journal ACS Chemical Neuroscience.

Hossam Haick and colleagues report have identified volatile organic compounds that can be associated with MS from exhaled breath. Based on these findings, the researchers developed a new sensor array that can diagnose MS by analyzing the determined chemical compounds that appear in the breath of people with MS. Using the developed sensors, the researchers carried out a proof-of-concept clinical study on 34 people with MS and 17 healthy volunteers and found that the developed sensors are just as accurate as a spinal tap but without the pain or the risk of side effects. 

"The results presented here open new frontiers in the development of fast, noninvasive, and inexpensive medical diagnosis tools for detection of chronic neurological diseases," the scientists stated. "The results could serve as a launching pad for the discrimination between different subphases of stages of multiple sclerosis as well as for the identification of multiple sclerosis patients who would respond well to immunotherapy." 

A large clinical study with the sensors is underway and will be reported in the future. Haick is a Professor in the Department of Chemical Engineering and the Russell Berrie Nanotechnology Institute at the Technion – Israel Institute of Technology. 

BG-12 Moves Forward with Positive Data from Late-Stage Trials
Positive top-line results have been reported from CONFIRM, the second of two pivotal phase III clinical trials designed to evaluate the investigational oral compound BG-12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS). Results showed that 240 mg of BG-12, administered twice a day (BID) or three times a day (TID), demonstrated significant efficacy and favorable safety and tolerability profiles. Further analyses of the CONFIRM study are ongoing, and Biogen Idec, the company developing BG-12, anticipates presenting detailed data at a future medical meeting.

BG-12 met the CONFIRM study's primary endpoint by significantly reducing annualized relapse rate (ARR) by 44 percent for BID and by 51 percent for TID versus placebo at two years. The CONFIRM study's reference comparator, glatiramer acetate (GA; 20 mg subcutaneous daily injection), reduced the ARR by 29 percent compared with placebo at two years. 

Initial results showed that BG-12 reduced 12-week confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS) by 21 percent for BID and 24 percent for TID at two years compared to placebo, and GA reduced confirmed disability progression by 7 percent. 

"We now have strong positive results for BG-12 in two robust pivotal clinical trials with more than 2,600 patients," said Doug Williams, Ph.D., Biogen Idec's Executive Vice President of Research and Development. "We are gratified by these strong efficacy and safety results, which, when combined with BG-12's oral route of administration, position it as a potentially important MS therapy. We are working aggressively to prepare our regulatory submissions with the goal of making BG-12 available to MS patients as quickly as possible." 

In CONFIRM, both dose regimens of BG-12 showed favorable safety and tolerability profiles, which were similar to those seen in the previous late-stage study known as DEFINE. Overall, the incidence of adverse events (AEs), serious adverse events (SAEs) including serious infections, and discontinuations due to AEs were similar across all study groups, including placebo. The incidence of hepatic and renal events was also comparable among all study groups. The most common AEs in the BG-12 groups were flushing and GI events. There were no malignancies in the BG-12 groups. 

Biogen Idec presented data from DEFINE, at the 5th Joint Triennial Congress of the European and Americas Committees on Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in October 2011.

 

Working Overnight or Odd Shifts May Increase MS Risk in Teens

Working overnight or odd shifts may increase teenagers' risk of developing MS, according to the results of an observational study. 

Researchers from Sweden who uncovered the link said interruption of circadian rhythms and disruption of normal sleep patterns may be partially responsible for the added risk.

In conducting the study, published in the Oct. 18th issue of Annals of Neurology, researchers examined two population-based studies of Swedish residents aged 16 to 70 (one with incident cases and one with prevalent cases) to compare the number of cases of MS among those who did and did not work overnight or shift hours on a regular or alternating basis during their teens.

Among the incident cases, the investigators found those who worked overnight hours for three years or more before the age of 20 were twice as likely to develop multiple sclerosis as those who never worked night shifts. Among the prevalent cases, they noted, the teens who worked overnight hours were slightly more than twice as likely to develop the disorder.

"Our analysis revealed a significant association between working shift at a young age and occurrence of MS," Dr. Anna Karin Hedstrom, of the Karolinska Institute in Stockholm, said in a journal news release. "Given the association was observed in two independent studies strongly supports a true relationship between shift work and disease risk." 

The researchers explained the sleep restriction associated with working the night shift has already been shown to increase the risk for certain health problems, including heart disease, thyroid disorders and cancer, likely by interfering with melatonin secretion and increasing inflammatory responses. 

The authors pointed out that since MS is a central nervous system autoimmune inflammatory disorder that is linked to a person's environment, other lifestyle risk factors, such as sleep loss due to shift work, should also be considered.

The study authors noted that more research is needed to explain why the disruption of circadian rhythm and sleep loss increase teenagers' risk for developing MS.

 

MS Walking Problems Rarely Discussed

Most people with MS who have difficulty walking say it is the most challenging part of the debilitating disease, U.S. researchers say. However, a survey by Harris Interactive indicated 40 percent of people with MS rarely or never discuss walking problems with their doctor. 

The recent survey of more than 1,200 adults living with MS indicated 65 percent reported having trouble walking, the inability to walk, or difficulty maintaining balance at least twice per week. Seventy percent of those with walking issues say that's the toughest symptom to deal with.

In addition, a majority of people living with MS reported they experienced walking problems within the first few years after diagnosis, while among people diagnosed with MS within the past five years, 58 percent reported experiencing a mobility issue at least twice a week.

On average, people with MS ages 41 or younger who do discuss trouble walking with their doctor initiate the conversation only 46 percent of the time. An estimated 78 percent of these women and 62 percent of these men report that trouble walking makes getting around dangerous, the survey indicated.

In light of the increasing menu of therapeutic options, assistive technology, and medication to aid walking problems, conversations with your doctor may lead to solutions.

 

As always, the ongoing studies and research is much appreciated!  Being able to diagnose MS with just a breath is incredible!  Disruption of normal sleep habits increasing the risk of MS makes me reevaluate my sleeping habits and makes me think back to my teenage sleep patterns (probably not the best, but what teenager truly has good sleeping habits?).  I am always happy to hear that clinical trials are going well for up and coming therapies!  Go BG-12!  

Thanks for reading!  Hope everyone is well!

Comments & a CCSVI Update

I want to take a moment to thank everyone who has left a comment on this blog!  It is so amazing to know that people are reading and that my blog has an impact.  I think I had forgotten that, to some extent, until my last post (Too Long).  In response to that post, I got two very kind, very supportive, very positive comments.  It reminded me of why I started this blog and it reminded me that everyday is a blessing and that I need to stay optimistic.  Your comments lift my spirit and I appreciate your words!  I am so lucky to have such an amazing support system, from my family to my friends to the readers of my blog.  It warms my heart to know that people whom I have never met support me.  It is also always great to hear about other people's experiences with MS; it helps me remember that I am not alone in this fight and that there are so many people to be fighting for.  I hope and pray that someday soon we will have a cure.  Thanks again for your continued support and for your always appreciated comments!

And now . . . a CCSVI update from the MSAA:

Background Information on CCSVI and MS

Many questions still surround the possible connection between chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS). CCSVI is a complex condition involving changes in blood flow from the brain back to the heart, which some researchers theorize could possibly lead to activation of the immune system, excess iron deposits, loss of myelin, and other nervous system damage. With CCSVI, the veins located on the outside of the brain (extracranial cerebrospinal veins) - those designed to transport blood from the brain back to the heart - collapse and/or become blocked, a condition known as "stenosis." Studies have shown that when the normal blood flow is altered, especially when the flow of blood is reversed, the body may react with an inflammatory response.
Two years ago, Paolo Zamboni and others published the results of a pilot study in the December 2009 edition of the Journal of Vascular Surgery. In this article, lead investigator Dr. Zamboni describes an experimental procedure to widen the narrowed or blocked veins in a study of 65 MS patients. Some refer to this as the "liberation procedure," where angioplasty is performed using a tiny balloon inserted into an affected vein. From this small, open-label study, Dr. Zamboni noted that a portion of the patients with relapsing-remitting MS (RRMS) experienced fewer relapses and improvement in function.
Since these results were published, the CCSVI theory in MS has received a great deal of attention. While a small number of studies are underway, some MS patients are seeing vascular surgeons or interventional radiologists on their own to undergo speculative diagnostic and corrective procedures. Additionally, vascular specialists and neurologists are not always in complete agreement about the presence of this condition in patients with MS and the procedures.
Anecdotally, some individuals with MS who have undergone a procedure feel that they are experiencing some improvement in certain symptoms. Typically, these might include improvements in fatigue, heat sensitivity, sleep, concentration, and balance. Over time, some even attribute improvements in bladder issues, mobility, flexibility, and other symptoms to the procedure. Conversely, some patients did not see any improvement following the procedure.

Research Challenges with CCSVI and MS

The problem faced by the medical community in researching the CCSVI theory is two-fold. First, researchers need to prove whether or not CCSVI occurs more often in individuals with MS versus the general population, and if so, how it may be related to the disease. Further complicating the issue is the fact that no single procedure or protocol has been identified for its diagnosis, and a wide range of results can occur when using different imaging equipment, techniques, and technicians.
The second problem in researching the CCSVI theory involves treating the condition. Dr. Zamboni and others have used an angioplasty-type of treatment for opening closed veins with a tiny balloon that is inflated several times and then removed. Possible adverse events can include bleeding, heart arrhythmias, and rarely an allergic reaction to the dye used to illuminate the veins. Additionally, veins sometimes close (restenosis) in the months following the procedure. A second option is to insert a stent into the closed veins, which poses additional risks - such as the stent dislodging and moving to another area of the body - requiring immediate surgery. Even with the stents, scar tissue can sometimes form and clog the stent. Finally, doctors will still need to determine if and to what extent MS patients may benefit from such a procedure, and if the benefits outweigh the risks.
More than 50 articles on the subject have appeared in peer-reviewed publications over the past two years, although many present conflicting results - with some finding significant proof of CCSVI in MS patients, and others finding no evidence - a problem often blamed on the lack of a protocol for specific diagnosis. Doctors are also looking at possible relationships between CCSVI and known risk factors for MS, including Epstein-Barr virus, genetic factors, Vitamin D deficiency, and cigarette smoking.
Experts agree that a strict protocol for testing will need to be developed, that a combination of tests may be required for a confirmed diagnosis of CCSVI, and that the operators performing these tests will need specialized training for consistent results. Another impressive hurdle in these studies is the issue of blinding. The researchers, doctors, and operators performing the diagnostic tests and evaluating the patients after the procedures need to be blinded as to who has MS and who received the active treatment, or the results could be biased.

Current Studies and CCSVI Registry

Studies may be found by visiting www.clinicaltrials.gov and searching for "CCSVI and multiple sclerosis." Many of the studies are listed as still recruiting participants, but interested individuals should check with the contact person listed for the most current information on recruitment. Currently, seven studies are listed, with locations in New York, Texas, California, Poland, and Italy. In June 2011, the Canadian Institutes of Health Research announced that they will be proceeding with a Phase I/II clinical trial.
One of the studies listed is sponsored by the Hubbard Foundation, titled, "Multi-center Registry for CCSVI Testing and Treatment." Located in San Diego, California, the purpose is to develop a registry of patients evaluated and treated for CCSVI, looking at changes in quality of life. The Hubbard Foundation is looking for doctors and medical facilities that perform CCSVI testing and treatment to register under their IRB (Institutional Review Board) approval to conduct research and provide the outcome of those tested and treated for CCSVI.
In June 2010, the National MS Society and the MS Society of Canada committed more than $2.4 million to support seven new research projects focusing on the role of CCSVI in MS.

Closing Remarks

As with any unproven theory and treatment, interested patients are strongly encouraged to talk with their doctor, and if appropriate, participate in an approved clinical trial. Without a tested and proven protocol for the diagnosis and treatment of CCSVI, individuals could be putting themselves at risk. In July 2011, news arrived of a second individual with MS from Canada who sought treatment outside of the country and died due to complications. Although such tragic results are not common, individuals considering these types of procedures should be aware of the risks involved.
MSAA enthusiastically but cautiously supports the investigation of potential causes and treatments for MS, striving to communicate such research to the MS community as soon as any information becomes available. However, MSAA's policy is to consider patient safety as the top priority - recognizing that all prospective theories and experimental treatments need to be thoroughly studied through rigorous clinical trials.

For more information on CCSVI from the MSAA, visit the MSAA's news center.

Thanks for reading!

Too Long

It has been too long since I last posted and, for that, I am sorry.  I have been a little down lately and I haven't had the motivation to post.  I guess I am finally realizing what it means to have relapsing-remitting MS.  I have been experiencing some numbness, tingling, and L'Hermittes intermittently lately and it has been frustrating.  I had been doing very well with little to no symptoms at all, but lately I have noticed some flare ups.  I am still much better off than I could be and I am grateful for that, but I was really enjoying being in complete remission.  Relapses suck, even the less severe relapses.  My "flare ups" have not been particularly bad (nothing like my symptoms before beginning treatment), but they are noticeable, which is enough to put me in a bit of a funk. 
I did go for a run for the first time since my diagnosis.  I am trying to get back into a workout routine so I went for a jog and my entire lower half was numb by the end, plus I was experiencing L'Hermittes pretty bad.  Will continue to jog for awhile and hope that my symptoms don't get any worse.  I just need to stay as cool as possible (with winter on the way, that shouldn't be too difficult). 

In other news, a dog park just opened up about 2.5 miles from our house, so we took our puppy there today.  He was in doggy heaven; he loves playing with other dogs.  He listened well and played nice, so it was definitely a success!  We will have to take him back soon.

Enough about me.  A recent study found that "subjects who were born by Caesarean section had a significantly higher risk of developing MS. The authors conclude that their results suggest those born by vaginal delivery are at a lower risk of subsequent MS, but that much larger and preferably prospective studies are needed."  This is very interesting to me; I am not sure how this would affect risk of developing MS, but apparently it may be a contributing factor.

For a limited time only, every donation made to the NMSS is doubled. Go to the NMSS website today to make a donation!!!

Follow up - MSF News

Now, more from the MSF email:

FDA Approves Botox to Treat Urinary Incontinence with MS

The U.S. Food and Drug Administration has approved Botox® (onabotulinum toxin A) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.

Uninhibited urinary bladder contractions in people with some neurological conditions can lead to an inability to store urine. Current management of this condition includes medications to relax the bladder and use of a catheter to regularly empty the bladder. The approved treatment consists of Botox being injected into the bladder resulting in relaxation of the bladder, an increase in its storage capacity, and a decrease in urinary incontinence.

"Urinary incontinence associated with neurologic conditions can be difficult to manage,” said George Benson, deputy director, Division of Reproductive and Urologic Products. “Botox offers another treatment option for these patients."

Injection of the bladder with Botox is performed using cystoscopy, a procedure that allows a doctor to visualize the interior of the bladder. Cystoscopy may require general anesthesia. The duration of the effect of Botox on urinary incontinence in people with bladder overactivity associated with a neurologic condition is up to 10 months.

The effectiveness of Botox to treat this type of incontinence was demonstrated in two clinical studies involving 691 patients. The participants had urinary incontinence resulting from spinal cord injury or MS. Both studies showed statistically significant decreases in the weekly frequency of incontinence episodes in the Botox group compared with placebo.

In addition to its use to improve the appearance of facial frown lines, Botox also is FDA-approved to treat chronic migraine headaches, certain kinds of muscle stiffness and contraction, severe underarm sweating, abnormal twitch of the eyelid, and a condition in which the eyes are not properly aligned.

The most common adverse reactions observed following injection of Botox into the bladder were urinary tract infection and urinary retention. Those who develop urinary retention after Botox treatment may require self-catheterization to empty the bladder.

Botox is marketed in the United States by Allergan Inc., of Irvine, Calif. 

Laquinimod Faces Hurdles
Teva Pharmaceutical Industries, Ltd. faces growing challenges and uncertainty surrounding its MS treatments, according to an Oppenheimer analyst.

The Israeli drugmaker said that its experimental drug, laquinimod, an oral MS treatment, did not reduce patients' annual relapse rates in a late-stage clinical trial. The study involved 1,331 patients who were treated with one of three options: laquinimod, a placebo, or Avonex, an older MS drug made by Biogen Idec, Inc.

Teva said MRI scans showed the patients in the laquinimod and Avonex groups had more brain lesions, which indicates they had more severe multiple sclerosis, and if study results are adjusted to remove that imbalance, laquinimod met its main goal of lowering the relapse rate.

Teva and its partner Active Biotech still plan to seek approval of laquinimod in the U.S. and the European Union. In December, the companies said the drug met its main goal in its first late-stage trial.

Analyst Christopher Holterhoff said in a research note it is unclear whether the U.S. Food and Drug Administration will accept adjusted data from the latest study as meaningful or require Teva to run another study.

"We are unaware of a precedent case where an MS drug was approved without two statistically significant trials," the analyst wrote.

Free Smartphone App Helps Keep Track of Injections
A free smartphone app, TrackMyShots, is available to help ease the log-keeping of people with MS, diabetes, and other conditions requiring frequent injections.

The app eliminates the need for bulky log books by allowing the user to record each injection, track injection sites, and monitor adverse reactions. Users can set up an ongoing schedule for their injections and get email alerts when it is time for their next shot.

Developed by Linxter, Inc., a software development company in Cooper City, Fla., the app was created to help a family friend with MS, says company CEO and founder Jason Milgram.

“She had carried around a bulky paper logbook for years,” Milgram said. “She and her husband asked if I could help develop an app that would allow her to keep track of the injections.”

The app’s initial release is available for Windows Phone 7 users. An Android version was scheduled to be available in late August, and iPhone users will be able to access the app in late September.

TrackMyShots, http://trackmyshots.com, recently received a Hero of the Week award from Microsoft, which “honors excellence in the field of app development.”

Definitely going to look into that app!  It looks as though Gilenya may continue to be the only available oral treatment for awhile.

Homecoming

This weekend was my 10 year high school reunion.  Got to see a lot of great people and learn what everyone is up to these days.  It was great to see everyone, but I am a little sad that I didn't get to catch up with everyone; there just was not enough time.  It was a lot of fun though and hopefully we can all get together again soon!  And maybe I will do a better job keeping in touch with people.

And now for the MS info :-)  The following comes from my MSF e-mailer:

Number of Genes Linked to MS More than Doubles
The largest-ever gene study of MS has identified 29 new genetic variants associated with the disease, confirmed 23 previously known genetic links, and suggested five more genes that may contribute to the disease.

Scientists regard the findings, recently published in the journal Nature, as significant for two reasons:  Because many of the genes linked to MS are involved in regulating the immune system –  specifically, the development of T cells – this boosts speculation that the disease is primarily an autoimmune disorder. It also gives researchers new targets for future treatment strategies.

For the study, scientists compared DNA from nearly 10,000 people with MS with DNA from more than 17,000 unrelated, healthy individuals. The researchers were affiliated with the International Multiple Sclerosis Genetics Consortium and the Welcome Trust Case Control Consortium.
They said the newly-found links point to the idea that T-cells – a type of white blood cell responsible for mounting an immune response –   and chemicals called interleukins play a key role in the development of the disease.

Drugs that target the immune system include rituximab, sold under the brand name Rituxan® by Roche and Biogen to fight leukemia, Tysabri® from Biogen and Elan, Lemtrada, sold as Campath® by Sanofi's unit Genzyme for cancer, and Abbott and Biogen's Zenapax® or daclizumab. Mid-stage trial data for daclizumab recently showed the drug on a par with other new medicines for MS, but some of the side-effects were worrisome.

Experts think both genetic and environmental factors are equally important in determining who is likely to develop MS, and taken together, the known genetic variants probably explain about 20 percent of the genetic links, they said.
In a second study reported in the Public Library of Science journal PLoS Genetics, researchers found that many of the genes linked to MS are also linked to other autoimmune diseases such as Crohn's disease and Type 1 diabetes. This also points to potential new uses for existing drugs in development, they said.
Previous research has suggested a link between Vitamin D deficiency and an increased risk of MS. Compston's team said that along with the many genes which play a role in the immune system, they had also found two involved in the metabolism of Vitamin D – which mostly comes from sunlight – lending weight to a possible link between genes and the environment.

"We have known for some time that many devastating diseases of the immune system must have common genetic causes," said Chris Cotsapas of Yale University in the United States, who led the PLoS study. "Now we have the outline of a map that tells us where we can look for common treatments."

In 2007, only three genes were linked to MS.

Research Identifies How Vitamin D Combats MS
New research has indicated that vitamin D directly terminates the production of a disease-causing protein, a discovery that may explain the association between levels of vitamin D in a person’s body and the person’s ability to resist or minimize the effects of MS.

According to the investigators, a collaborative team of scientists from the University of Medicine and Dentistry of New Jersey and Stanford University, the mechanism they identify suggests what might be a new path toward pharmaceutical treatment of MS, as well as therapies for other autoimmune diseases. The mechanism identified by the research team works like this:

During MS (“EAE” in mice), a damaging protein called interleukin-17 (IL-17) is produced by immune cells in the brain.

After vitamin D binds to its receptor, the receptor parks itself on the gene that encodes IL-17.

By doing so, the vitamin D receptor occupies a site normally reserved for a protein called NFAT, which is required to turn the IL-17 gene on.

The gene stays off and IL-17 levels plummet.

At the same time, the vitamin D receptor turns on another gene, whose product generates suppressive T cells that combat the destructive action of their IL-17-producing counterparts.

The study is published in the September issue of the journal Molecular and Cellular Biology.

Unique Trial uses Adult Stem Cells to Treat MS
The Cleveland Clinic, the University Hospitals Seidman Cancer Center, and Case Western Reserve University are collaborating on a one-of-a-kind clinical trial in the United States which uses a person’s own adult stem cells to treat MS and perhaps even reverse damage caused by the disease.

Mesenchymal stem cells, or MSCs, are found in the bone marrow and are not the embryonic stem cells that have stirred controversy in political and religious arenas.

In the phase one trial, a person’s MSCs are harvested, carefully cultivated in a special laboratory and then injected intravenously back into the individual. Since June, three people have undergone the entire process. A total of 24 participants with relapsing or progressively worse MS who have moderate to severe disability will take part in the study over the next two to three years.

The primary aim is to test the feasibility and safety of using the body's own stem cells to treat MS. But researchers also are looking closely for any preliminary evidence that the transplanted cells could moderate the over-active immune system, possibly stopping or even repairing tissue damage.

If promising results lead to a larger, multicenter clinical trial that also yields good outcomes then the treatment could be offered in a clinical setting within five to seven years, researchers involved in the study told the Cleveland Plains Dealer.

More than 150 other clinical trials in the United States and around the world are currently testing MSCs' ability to encourage tissue repair as a way to treat a variety of other conditions such as osteoarthritis, diabetes, emphysema, and stroke. Stem cell therapy is already used to treat leukemia, lymphoma, and certain blood disorders.

 The next post will have more from the MSF e-mailer - there is some really interesting stuff in this most recent e-mailer!  I love learning more about vitamin D and stem cell research!  It is so great that this research continues; I am so hopeful that a cure will come in my lifetime!

A Little Bit of This, A Little Bit of That

Random excerpts from my MSIF e-mailers:

A good reason to find a doctor that you like: An "study from Italy found that a good physician-patient relationship improves both patient satisfaction and adherence to long-term therapy."

A randomized trial of new drug, Simvastatin, "involved giving 80 mg Simvastatin daily for six months to people with optic neuritis. The results suggest that this is well tolerated and possibly effective in patients with acute optic neuritis."

"Alemtuzumab, a candidate treatment for MS, has the potential side effect of autoimmune disease. In this study, the authors analyse both clinical and serological data of patients with MS treated with alemtuzumab. It was found that autoimmune disease developed in 22.2% of those treated with a range of different systems affected."



And now, from the NMSS website, What Causes MS in Kids?:

Investigators nationwide are recruiting 640 children with early relapsing-remitting MS or CIS (clinically isolated syndrome, a single episode of MS-like symptoms) and 1280 children without MS or CIS for a four-year study to determine environmental and genetic risk factors that make children susceptible to developing MS. The study, funded by the National Institutes of Health, leverages the National MS Society’s support of the Promise:2010 Pediatric Network of Centers of Excellence.
Background: This study takes advantage of the collaborative efforts of the Pediatric Network. Although the initial grants end this year, there is funding through 2012 to support a data coordination and analysis center so the Network can continue to collect data and study pediatric MS and related disorders. The Network produced over 150 papers, posters and presentations on pediatric MS and network members are the lead authors and editors of a textbook on Pediatric MS from Cambridge Press.
The five-year, $3.2 million grant to lead investigator Dr. Emmanuelle Waubant (University of California, San Francisco Pediatric MS Center) from the NIH is based on pilot data collected by the Network in a study of 180 children with MS. That study confirmed previous reports that the Epstein-Barr virus (which causes infectious mononucleosis and other disorders) was associated with higher risk of MS. They also reported that cytomegalovirus was associated with a lower risk of developing MS, and that herpes simplex virus type 1was associated with increased risk in children who did not have a specific immune-related gene. (Neurology 2011;76:1989–1995)
These findings and other factors are being investigated further in the new study, which should help us understand more about how MS begins in children and can eventually be applied to adult forms of MS. Read more about what triggers MS.
The Study: Those under age 18 who had disease onset (MS or CIS) in the last two years may enroll in this study with the consent of their parents. Children without MS or CIS can enroll if they are 19 or younger and don’t have a demyelinating disease or an autoimmune disorder (except asthma).
Participants are providing blood samples to test for genetic and environmental risk factors that may be associated with pediatric MS. Next, all participants are completing questionnaires about relevant environmental factors. Investigators also will draw information from participants’ medical records.
Investigators specifically are looking at genes, Epstein Barr and other common viruses, vitamin D levels, and exposure to cigarette smoking. They are attempting to confirm these risk factors separately and to determine whether there are any interactions between them.

It would be great to have more answers!

Remembering . . .

I try not to stray from writing about MS on my blog, but today warrants recognition.  Ten years ago, a terrorist attack stunned America.  Today, we remember those who lost their lives that September day and we thank those who courageously worked and fought to save lives.
I may not be able to remember what I was doing last Tuesday, but I will never forget what I was doing on Tuesday, September 11th, 2001. 
Please take a moment to remember!

MS Birthday

Today, 9/8/11, is my MS Birthday - exactly one year ago, the doctor diagnosed me with MS and changed my life.  It is crazy to think that a year has come and gone; at the same time it is crazy to think that it has only been a year.  It was April 2010 when I first began noticing MS symptoms and the search for a diagnosis started.  It was April or May 2010 when MS was first mentioned to me as a possibility.  So in a way, it feels like it has been longer than a year.  However, even though everything began in April 2010, I was not diagnosed until 9/8/10 and it wasn't until October 2010 when I first started taking medication for MS.  It certainly does not feel as though it has been a year since I heard those fateful words from the neurologist, but alas, it has been one whole year. 

In the last year I have gone from numbness in my feet and legs to numbness in my left hand, to no numbness; from L'Hermittes constantly bothering me to only bothering me when my core temperature goes up to not bothering me at all; from tingling when my core temperature rises to no tingling at all and back to tingling when my core temperature rises; from pain in my right eye (probably optic neuritis) to no pain to intermittent pain recently (usually at night); from fatigue to severe fatigue and back again (fatigue never really seems to go away, but I am never sure if it is solely caused by MS or a combination of MS, stress, lack of sleep, etc.).  I am sure I could list other "ailments," but those are the main ones.  Overall, I am feeling pretty good lately; generally, the only reminder of my MS I have is my daily shot (which I must say really does get old - I just want a break from it sometimes, but I forge on).

While I certainly am not celebrating a year with MS, I do celebrate the fact that I am doing well overall.  I am celebrating the continuing research that is being done and the hopes of someday having a cure!